Kornimate/medical-research-clean huggingface dataset:
a study to examine patient characteristics, health care management and health outcomes of hepatitis c virus (hcv) patients treated with simeprevir

Conditions: Hepatitis C Virus

Summary: the purpose of this study is to evaluate the effectiveness of a simeprevir-containing hepatitis c virus (hcv) treatment regimen as measured by sustained virologic response (svr).

this is a multicenter, observational (a study in which the investigators/ physicians observe the patients and measure their outcomes), prospective study (a study in which the patients are identified and then followed forward in time for the outcome of the study) designed to reflect routine clinical practice. approximately 300 hepatitis c virus (hcv) infected patients who are prescribed simeprevir by their health care provider as part of their routine hcv treatment regimen, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (\<=) 28 days will be enrolled in this and observed to evaluate the effectiveness of a simeprevir. practice setting features will be documented at the initiation of the study by each participating site. the decision of patients to participate in this study will in no way impact upon the standard of care that they are receiving. all treatment decisions will be made at the discretion of the health care provider. safety assessments will include assessment of adverse events, and clinical laboratory parameters (hematology, clotting tests, human immunodeficiency virus tests, chemistry, and liver function tests). the maximum study duration for each patient will be approximately 2 years.

Eligibility criteria:
inclusion criteria: * patients who have genotype 1 chronic hepatitis c infection * hepatitis c virus (hcv) ribonucleic acid (rna) test result above the limit of quantification before initiation of simeprevir-based therapy * health care provider decision to treat patient with a simeprevir-based therapy, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (\<=) 28 days will be enrolled into the study * prior hcv treatment must be completed more than 3 months before initiation of simeprevir-based therapy * in the opinion of the health care provider, the patient will attend routine standard of care visits, either at enrolled site or by virtual/telemedicine exclusion criteria: * non-genotype 1 hcv infected patients * absolute contraindication to any component of prescribed hcv treatment per prescribing information * patient is currently enrolled in an interventional study * past use of an hcv direct-acting antiviral therapy * any investigational drug use within 30 days before initiation of simeprevir-based therapy

Keywords: hepatitis c virus simeprevir ribonucleic acid sustained virologic response
a study of arry-371797 in patients with active ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this is a phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug arry-371797 (versus placebo) in treating ankylosing spondylitis, and to further evaluate the drug's safety. approximately 130 patients from the us, canada, poland and hungary will be enrolled in this study.


Eligibility criteria:
key inclusion criteria: * diagnosis of ankylosing spondylitis according to the modified new york criteria (1984). * inadequate response to at least 2 weeks of continuous treatment with nsaids, or unable to receive ≥ 2 full weeks of continuous treatment with nsaids because of intolerance. * if previously treated with a biological agent, patient must not have failed due to lack of efficacy, and must have completed an appropriate washout period prior to first dose of study drug. * patients may continue on specified stable background therapies for ankylosing spondylitis (doses should be stable for at least 4 weeks prior to the first dose of study drug). * additional criteria exist. key exclusion criteria: * diagnosis of any other active or uncontrolled inflammatory or non-inflammatory articular disease that may interfere with disease activity assessments. * previously treated with intravenous immunoglobulins within 6 months prior to first dose of study drug. * patients requiring prohibited concomitant medications including moderate or strong cyp3a inhibitors, cyp3a inducers and biologic response modifiers (brms) while on study. * trauma or other major surgeries within 8 weeks prior to first dose of study drug. * specific abnormal laboratory values or electrocardiogram abnormalities. * known positive serology for human immunodeficiency virus (hiv), hepatitis c, and/or hepatitis b. * additional criteria exist.
knowledge and attitudes towards human papillomavirus infections and hpv vaccination

Conditions: HPV-Related Cervical Carcinoma

Summary: a better understanding of the target audiences about hpv infection and hpv vaccination would surely allow for a better spread of this vaccination in switzerland. in order to know if the target audiences are properly informed, we have decided to carry out a study evaluating their level of knowledge on a particular audience that are the men and women undergraduate nurse.


Eligibility criteria:
inclusion criteria: * eligible women and men aged between 18-36 years * understands study procedures and accepts voluntarily to participle of the study exclusion criteria: .don't understand french language
perioperative closed-loop glucose control

Conditions: Perioperative Hyperglycaemia; Insulin Therapy; Elective Surgery; Closed-Loop Glucose Control; Artificial Pancreas

Summary: the prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated with grater complication rates, length of stay and mortality rates. suboptimal glucose management in the perioperative setting remains a major barrier to optimal surgical care. while there are guidelines to manage perioperative diabetes care, implementation is challenging and inconsistent, in part due to a stretched workforce, involvement of several disciplines and clinical teams and shortcomings in clinical training and knowledge. closed-loop glucose control represents an emerging diabetes treatment modality that autonomously adjusts insulin delivery according to continuously measured glucose levels. the use of fully automated closed-loop insulin delivery may represent an easy-to-adopt approach for safe and effective perioperative diabetes management.


Eligibility criteria:
inclusion criteria: * written informed consent * the subject is aged 18 years or over * diagnosis of type 2 diabetes using standard diagnostic practice (37) * the subject is planned for an elective abdominal, thoracic or cardiovascular surgery at the university hospital bern expected to last ≥2 hours * the subject requires treatment with subcutaneous insulin as part of the perioperative glucose management * the subject is literate in german * the subject is willing to wear study devices 24/7 exclusion criteria: * physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator * known or suspected allergy to insulin * type 1 diabetes * pregnancy, planned pregnancy, or breast feeding * medically documented allergy towards the adhesive (glue) of plasters or unable tolerate tape adhesive in the area of sensor placement * lack of safe contraception for female participants of childbearing potential for the entire study duration (medically reliable method of contraception are considered oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or any other methods judged as sufficiently reliable by the investigator in individual cases). * serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor * illicit drug abuse or prescription drug abuse * incapacity to give informed consent * droplet/airborne isolation precautions * participation in another clinical trial that interferes with the interpretation of the study results
adoptive immunotherapy of high risk acute myeloblastic leukemia patients using haploidentical kir ligand-mismatched natural killer cells

Conditions: Myeloblastic Leukemia

Summary: aml patients with de-novo or secondary disease with age greater than 18 years not eligible for stem cell transplantation for medical contraindications, lack of donor or lack of stem cells,are eligible. leukemias other than aml and m3 fab subtype will be excluded from the study. immunosuppressive chemotherapy prior to nk cell infusion will include: fludarabine and cyclophosphamide 4g/m2 (flu/cy). the therapy will be administered over 6 days on inpatient basis. haploidentical nk cells will be selected from a steady-state large volume leukapheresis product from a suitable kir ligand incompatible donor. donor-recipients pairs will be selected on the basis of known kir ligands. in particular, haploidentical donors will be included if present at least one allele mismatch at a class i locus among the following ones: hla-c alleles with asn77-lys80, hla-c alleles with ser77-asn80, hla-bw4 alleles. immunomagnetic enrichment of nk cells will follow two subsequent steps: 1) depletion of cd3+ t cells followed by 2) positive selection of cd56+ nk cells. contaminating cd3+ t cells will be carefully evaluated.

when previously cryproserved nk cells are still available, further re-infusions may be performed, according to pi's evaluation. the number of remaining nk cells must be sufficient for the reinfusion of at least the minimum dose of cells (106/kg). at least two months should elapse between two consecutive infusion procedures.

Eligibility criteria:
inclusion criteria: * signed informed consent. * performance status ≥ 70% (karnofsky score) or ≤ 2 (who). * age greater than 18 years. * availability of a kir incompatible haploidentical donor. * adequate renal (serum creatinine \< 2 mg/dl), pulmonary (sat o2 ≥ 96%) and hepatic (alt/ast \< 2.5 x n) function. * patients enrolled in the protocol must have an autologous graft cryopreserved to be reinfused in case of severe myelosuppression induced by haploidentical nk cells. back-up cells will be reinfused in case of anc \< 0.5 x 109/l at day + 40 from the start of immunosuppressive regimen. exclusion criteria: * age \< 18. * people unable to give informed consent. * hiv positivity. * hcv positivity with high viral load. * intercurrent organ damage or medical problems that would interfere with therapy. * pregnant or nursing females. * current uncontrolled infection. * no availability of a cryopreserved autologous stem cell graft to be reinfused in case of severe myelosuppression. * signs or symptoms of fluid retention (e.g. pleural effusion)

Keywords: nk cells infusion minimal residual disease in aml patients trafficking of nk cells after infusion cytolytic effects on leukemic cells
safety and efficacy of agn-210961 ophthalmic solution compared with bimatoprost ophthalmic solution in patients with glaucoma or ocular hypertension

Conditions: Ocular Hypertension; Primary Open-Angle Glaucoma

Summary: this study has 2 parts. part 1 will evaluate the safety and iop effects of 6 formulations of agn-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. part 2 will evaluate the safety and iop effects of a formulation (to be selected from part 1) of agn-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.


Eligibility criteria:
inclusion criteria: - ocular hypertension or primary open-angle glaucoma in each eye exclusion criteria: * any active ocular disease * anticipated wearing of contact lenses during study * anticipated use of artificial tears during study * contraindication to pupil dilatation
pet tracer based fdg signal for predicting prognosis in acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to evaluate the predictive value of 18f-fdg pet probe signal in de novo diagnosed or refractory/relapsed patients with acute myeloid leukemia. it is hypothesized that the intensity of 18f-fdg signal, an indicator of glucose uptake capacity, in various cell subsets of bone marrow will improve the predictive effect of clinical standard prognostic work-up.

rationale: fdg is incorporated by leukemia cells and other cell subsets in bone marrow micro-environment of various degree. the heterogeneous fdg uptake is a promising marker for predicting response to treatment. the investigators will collect bone marrow under standard clinical work-up after 18f-fdg pet/ct scan and correlate the fdg signal intensity with clinical and genomics features of the patients to explore its prognostic significance. objective: the primary objective of this research project is to investigate the intensity of fdg pet probe based glucose uptake signal in predicting induction treatment response of aml. as secondary objectives, this analysis will be applied to calculate the overall predictive specificity and sensitivity of fdg probe avidity in predicting pfs and os.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute myeloid leukemia, non apl * eastern cooperative oncology group (ecog) performance status of 0 to 2 * patients voluntarily participated in this study and signed the informed consent exclusion criteria: * pregnant * uncontrolled systemic diseases (such as diabetes, non controlled heart failure, etc.)

Keywords: acute myeloid leukemia bone marrow micro-environment 18f-fluorodeoxyglucose cancer metabolism
a study on the effect of renal impairment on the pharmacokinetics of ro4917838

Conditions: Healthy Volunteer

Summary: this open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of ro4917838 in healthy and renal impaired subjects. subjects will receive a single dose of ro4917838.


Eligibility criteria:
inclusion criteria: general criteria * body mass index (bmi) between 18 and 32 kg/m2 criteria applying to renal impaired subjects * adult subjects, 18-65 years of age * part 1: subjects with end stage renal disease (esrd), not on dialysis * part 2: subjects with severe, moderate or mild renal impairment * stable renal function criteria applying to healthy subjects * adult subjects, 18-70 years of age exclusion criteria: general criteria * any condition or disease (other than renal impairment for the renal impaired subjects only) that would render the subject unsuitable for the study, or would place the subject at undue risk * any condition which could relapse during or immediately after the study * history of alcohol or drug abuse criteria applying to renal impaired subjects * evidence of unstable clinically significant disease other than renal impairment * clinically significant liver disease * any other major illness (with the exception of renal impairment) within 4 weeks prior to study start criteria applying to healthy subjects * history of any clinically significant disease (e.g., cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic disease)
a study of the effectiveness of direct current stimulation for alcohol use disorders

Conditions: Alcohol Use Disorder

Summary: transcranial direct current stimulation (tdcs) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.it can modulate cortical excitability of target brain region, neuron plasticity and brain connections. previous studies suggest that tdcs could reduce cue-induced craving in drug addiction. objective:in this study, the investigators employed real and sham tdcs of the bilateral dorsolateral prefrontal cortex (dlpfc) to test the effect of whether it could reduce cue-induced craving, influence cognitive function in alcoholics and explore its underlying mechanism with functional magnetic resonance imaging (fmri). methods: the investigators perform a randomized sham-controlled study in which 40 inpatient alcoholics will be randomized to receive 10 sessions of 20min sham or 1.5ma tdcs to the bilateral dlpfc (anodal right/cathodal left). the neuroimaging data, craving after exposed to alcohol-associated cues and the cognition task at baseline and after stimulation will be collected. the investigators hypothesized that tdcs stimulating the dlpfc decreases cue-induced craving and improves cognition, which might be associated with the functional connectivity alterations.


Eligibility criteria:
inclusion criteria:(1)clinical diagnosis of severe aud defined in the diagnostic and statistical manual of mental disorders-fifth edition (dsm-5); (2)must be able to look and hear; (3) clinical institute withdrawal assessment of alcohol scale, revised (ciwa-ar) score less than 10. exclusion criteria:(1) clinical diagnosis of substance use disorder other than an alcohol or nicotine use disorder defined in the diagnostic and statistical manual of mental disorders-fifth edition (dsm-5)；(2) severe brain injury, stroke, seizure, epilepsy or other major neurological diseases ; (3) schizophrenia, bipolar disorder, depression or other axis i disorder of dsm-v criteria;(4)any contraindication for fmri scanning.
prospective evaluation of breast-conserving surgery alone in low-risk ductal carcinoma in situ (dcis)

Conditions: DCIS

Summary: to evaluate whether the combination of clinicopathological factors and the use of the oncotype dx dcis score can avoid radiation in women with low risk dcis who have had breast conserving surgery (bcs)

a prospective cohort study, conducted in canada, to prospectively evaluate whether the combination of clinicopathological criteria and the oncotype dx dcis score can identify a group of women at very low risk of local recurrence following breast conserving surgery who do not require breast radiation therapy. we plan to screen 809 consenting women who will have their tumour tissue specimen sent to exact sciences to assess their dcis score. we anticipate that 526 women will have an oncotype dx dcis score with a predicted 10-year risk of local recurrence ≤10%, these women will be enrolled and followed as part of the study. at each centre, all patients with dcis referred to radiation oncology will be documented. when a physician identifies an eligible patient, the patient will be approached by the referring physician or delegate to voluntarily provide informed consent to participate in this study. consenting patients will be registered through the ontario clinical oncology group's (ocog) web-based registration system. a two-step registration/enrollment process will be implemented. data related to the patient demographics, surgery details, tumour characteristics and ecog performance will be collected. the patient's tumour specimen will be sent for analysis to exact sciences. the dcis score results will be sent to the referring physician. ocog will also receive the dcis score results. patients will be followed yearly up to 10 years. bilateral mammograms and breast exams will be performed annually. the study data will be verified by source documentation.

Eligibility criteria:
inclusion criteria: 1. female patient \> 45 years of age with dcis without microinvasion. 2. tumour size ≤ 2.5cm. 3. treated by bcs with clear resection margins ≥ 2 mm or no residual disease on re-excision.\* \* patients with anterior margins and posterior margins ≥1 mm are eligible. or if the dissection was confirmed to be taken to skin and down to fascia with no dcis present at inked margins. 4. oncotype dx dcis score with a predicted 10-year risk of lr ≤10%. exclusion criteria: 1. multifocal dcis. 2. history of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast. 3. synchronous or previous invasive or non-invasive breast cancer. 4. prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers. 5. ecog performance status ≥3. 6. life expectancy \<10 years. 7. geographic inaccessibility for follow-up.

Keywords: ductal carcinoma in situ breast conserving surgery oncotype dx ds
efficacy of dihydroartemisinin for treating pcos

Conditions: Polycystic Ovary Syndrome

Summary: the primary research hypothesis of this study is that dihydroartemisinin is effective in restoration of regular menstrual cycles of pcos subjects who meet at least two of three rotterdam criteria. secondary research hypotheses include: dihydroartemisinin is also effective in reducing androgen, total immature follicles, and anti-mullerian hormone.

polycystic ovary syndrome (pcos) is a common reproductive endocrine metabolic disorder caused by genetic and environmental factors. artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. in recent years, artemisinin has also been reported to have significant anti-inflammatory, anti-tumor and immune-modulating effects. our recent study revealed that artemisinin derivatives protect against pcos development by inhibiting ovarian androgen production. consistently in a small pilot study, dihydroartemisinin effectively reduced androgen levels, reduced immature follicles, and improved the estrous cycle in pcos patients who strictly met all the three rotterdam criteria, namely hyperandrogenism, ovulation dysfunction, and polycystic ovaries on ultrasound. nevertheless, clinical diagnosis of pcos can be established as long as a patient fulfill two of the three rotterdam criteria. the present study aims to explore the therapeutic effects of dihydroartemisinin in patients with pcos who met at least two of three (≥2) rotterdam criteria.

Eligibility criteria:
inclusion criteria: * bmi 18.5-28kg/m2 * no plan for pregnancy in the coming 6 months * patients should meet two of the three following criteria: 1. irregular cycles and ovulatory dysfunction: \ 35 days or \ 90 days for any one cycle 2. polycystic ovaries: ≥12 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound. 3. elevated androgen levels: total testosterone\>1.67 nmol/l. exclusion criteria: * pregnancy. * patients with other endocrine diseases that can cause secondary pcos, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, cushing's syndrome, etc. * patients with other serious diseases affecting heart, liver, kidney, or other major organs. * patients with any type of cancer.
insulin resistance in women with prolactinoma

Conditions: Prolactinoma; Insulin Resistance; Hyperlipidemia

Summary: prolactin is suggested to influence insulin resistance, but scarce data is available on the metabolic profile of patients with prolactinoma. the purpose of the protocol was to evaluate cardiovascular disease risk factors in women with prolactinoma treated with dopamine agonists and to study the influence of disease control and anthropometry on their metabolic profile.

a cross-sectional study was performed in non-obese premenopausal women with prolactinoma treated with dopamine agonists evaluated regarding glucose, insulin, homeostasis model assessment (homa), lipid profile, c reactive protein (crp), body mass index (bmi), waist circumference, prolactin, estradiol, testosterone, and sex hormone binding globulin (shbg). they were compared with control women of similar age and bmi distribution.

Eligibility criteria:
inclusion criteria: * prolactinoma * female gender * premenopausal exclusion criteria: * obesity (bmi ≥ 30 kg/m²) * diabetes mellitus * hypertension * gh deficiency * hypothyroidism * primary hypogonadism * adrenal insufficiency * pituitary surgery

Keywords: insulin glucose lipids prolactinoma hyperprolactinemia